MAUDE Adverse Event Report: TRUMPF MEDIZIN SYSTEME GMBH + CO. KG OP-TISCH SATURN SELECT 3.02; SURGICAL TABLE

Model Number 1522235

Device Problem Overheating of Device (1437)

Patient Problem Burn(s) (1757)

Event Date 05/10/2022

Event Type  Injury  

Manufacturer Narrative

The customer has had both tables since 2014 and only recently have the injuries been noted.The two tables are in different operating rooms on the gynecology service line.The customer notes when cleaning the seat section with a damp cloth post the procedure, the liquid evaporates immediately due to the extreme heat and this scenario happens one time after 10 operations.Surgical staff confirmed both tables were being used on 24v battery mode only, there was no main power cable plugged in and no audible or visual message/alerts from the devices.It is additionally noted that the customer clinic electric department checked the ground installation with no issues noted.Hillrom currently has two complaints for both or tables involved with injury.Follow-up attempts were made with the customer; however, they could not provide any further details of medical intervention, delayed/prolonged diagnosis ¿ treatment or hospitalization, total time for the procedure, cautery use, grounding pad location, new electrical equipment placed/installed in the two or rooms, if the device still overheats with use of the power cable and cleaning agent being used.Inspection of the device by a hillrom technician found no sign of damage or failure.The mechanical/ electrical table components were noted to be functioning as designed and no trace of burns or failures were identified.The inspection states the problem is 99.9% not related to the table itself except that the table could be the vessel of an electrostatic charge.Hillrom has checked the table electronics and there is no sign of failure or heat, also the electrical safety check shows no current leak in the table.The device was found to be functioning as designed; however due to the customer allegation and potential for serious injury to be involved with the patient¿s burn, hillrom is cautiously reporting this event.If new relevant information will become available a follow-up report will be submitted.

Event Description

It was reported by the customer that the seat section of two saturn operating tables becomes hot during use and have seriously burned several patients to their back area during gynecology surgeries.The patients are pregnant women hospitalized to give birth and between the ages of 28-40.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: OP-TISCH SATURN SELECT 3.02
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): TRUMPF MEDIZIN SYSTEME GMBH + CO. KG; carl-zeiss-strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• Manufacturer Contact: steffen ulbrich ; carl zeiss strasse 7-9; saalfeld thuringen 07318 ; GM 07318
• MDR Report Key: 14569706
• MDR Text Key: 293452755
• Report Number: 3007143268-2022-00012
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00887761988316
• UDI-Public: 887761988316
• Combination Product (y/n): N
• Reporter Country Code: TS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1522235
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other